| Primary Device ID | 00875197006278 |
| NIH Device Record Key | 445265a5-05d1-4279-bbe0-cba62b7a8017 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | cobas® BKV |
| Version Model Number | 08688249190 |
| Catalog Number | 08688249190 |
| Company DUNS | 071674100 |
| Company Name | Roche Molecular Systems, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00875197006278 [Primary] |
| QLX | Nucleic acid amplification test for the quantitation of epstein-barr virus (EBV) DNA |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-10-08 |
| Device Publish Date | 2020-09-30 |
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| 04015630936557 - DOCKING STATION SHORT | 2022-09-16 |
| 00875197006445 - cobas® NHP Negative Control Kit | 2022-08-09 |
| 04015630929009 - cobas x 480 Analyzer | 2022-06-10 |
| 00875197006391 - cobas® HCV | 2021-12-22 |
| 00875197006407 - cobas® HIV-1 | 2021-12-22 |